The Ocular Coil Drug Delivery Comfort Trial
The administration of drugs to the eye is normally done by means of eye drops. For most patients this is easy to do, but there are disadvantages to this route of administration. For example, when applying eye drops only a proportion of the drops are retained in the eye leading to a low amount of drug being absorbed by the tissue. To counteract this, frequent administration with high drug concentrations is required, which can result in side effects or low levels of patient compliance. A new implant is being developed in the form of a flexible rod that is placed under the eyelid in the conjunctival fornix. This rod comprises a unique biomaterial that can deliver a drug over a period of weeks to months. This innovative way of drug administration results in better patient compliance with fewer side effects and improved delivery of drug to the front of the eye.
Project status 2016-2017
The project had a successful start and by the beginning of 2018, OCDC is expected to have the clinical grade drug-loaded microspheres. This means that the first step for going from bench to bedside has been taken. After the microspheres are tested, the ocular coil needs to be tested as well. These results are planned to be ready in the beginning of 2019. The next step will be to evaluate the ocular coil in a large cohort of patients. These clinical evaluation studies would be working towards providing the ocular coil as medical device to the clinic.
Project Status 2017-2018
In 2017, the OCDC team made significant progress in order to optimize, refine and freeze the production process of coils filled with placebo microspheres. These placebo-loaded coils will be used to evaluate the coil’s comfort, as it is key that patients can tolerate the coil implant for longer periods. Currently, the clinical batch of placebo-loaded coils is being produced. The clinical protocol was also updated with input from quality experts and with the latest technical information. The comfort study is expected to start in mid-2018, and the first results are anticipated in November 2018.
Besides comfort, sustained drug delivery capacity of the coil filled with drug-loaded microspheres will be evaluated in order to show that the ocular coil is effective as a drug delivery system. In 2017, we worked with various parties in order to develop and produce drug-loaded microspheres. We expect to have the drug-loaded microspheres by mid-2018. These drug-loaded microspheres will then be used for the production of drug-loaded microsphere filled coils. The efficacy study is planned for the second half of 2018.
Prof. Rudy Nuijts, MD, PhD
Maastricht University Medical Center
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